Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05581979 |
| Other study ID # |
PSMA 01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2022 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
February 2024 |
| Source |
National Cancer Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objectives of this pilot feasibility study, which is on the use of 68-Ga PSMA PET imaging
of salivary gland tumours, are
- to determine the proportion of patients with high PSMA-ligand uptake on Ga-68 PSMA
imaging in locally advanced, recurrent or metastatic salivary gland cancers and other
rare cancer; and
- to determine if in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA
imaging in locally advanced, recurrent or metastatic salivary gland cancers and other
rare cancers.
The hypotheses of this study are that there is high PSMA-ligand uptake on Ga-68 PSMA imaging
in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers;
and that in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging.
Description:
The potential participant will be screened and confirmed for eligibility by the appropriate
study-team member. A signed IRB approved informed consent will be obtained prior to
conducting any study-related procedures.
On the scheduled visit date for the study,
- An intravenous cannula (plug) will be inserted in a vein in the participant's arm,
through which the 68-Ga PSMA radiotracer for the scan will be injected. The infusion
will take about 1-2 minutes.
- PET imaging will be performed with a dedicated PET/CT scanner. 2.5-6.0 mCi (depending on
weight of the patient) of PSMA radiotracer will be injected intravenously.
- A PET scan will be done around 60 minutes after the injection of the 68-Ga PSMA imaging
agent.
- During imaging, the participant will be asked to lie still and may be asked to hold
his/her breath for a few seconds.
- Imaging will be performed using a PET/CT, which will take 30 to 40 minutes to complete.
Imaging of the body from vertex to mid thigh or feet will be obtained.
- After the completion of the scan, the plug will be removed.
A Final Study Visit will take place on that one scheduled day. The participant will not need
to visit the doctor's office during the course of the study outside of their usual scheduled
doctor's follow up appointments.
